Manager/Sr. Specialist - Clinical Supply Chain
- 111 Oyster Point Blvd, South San Francisco, CA 94080, USA
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics. FivePrime has a differentiated discovery platform and capabilities that is fueling a growing portfolio of development candidates.
Our pipeline includes:
- Cabiralizumab (FPA008), an anti-CSF-1R antibody currently in development in a Phase 2 trial in pigmented villonodular synovitis (PVNS) and a Phase 2 trial in second-line pancreatic cancer
- FPA144, an anti-FGFR2b antibody currently in a Phase 1/3 clinical trial in FGFR2b over-expressing gastric cancer
- FPA150, an anti-B7H4 antibody will enter Phase 1 clinical development in the first half of 2018
- FPT155, a CD80 fusion protein, which is in IND-enabling studies
We have entered into strategic discovery and development collaborations with leading pharmaceutical and biotech companies, including Bristol-Myers Squibb, GSK, UCB and Zai Labs.
FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products. Discover more about FivePrime at www.fiveprime.com.
Five Prime Therapeutics, Inc. is seeking a motivated and ambitious individual to join our clinical Supply Chain. The individual will represent Supply Chain at Study Execution and CMC Team Meetings. This position reports to Associate Director, Supply Chain.
- Create and maintain study level demand plans and timelines
- Scheduling and Management of packaging runs at external vendors and their release
- Coordination of Post Labeling ID Testing at external vendors
- Label Text and Proof approval at external vendors
- Packaging component approval at external vendors
- Pre/Post Operation Batch Record review and approval
- Management of Distribution operations at external vendors
- Formulate study level supply strategy
- Vendor management oversight to ensure clinical trials are supplied with product, ensure inventory levels are maintained at depots. Vendor management oversight to ensure clinical trials are supplied with product, ensure inventory levels are maintained at depots.
- Oversight of Returns and Accountability at external vendors, provide guidance for returns for destruction
- Leading Supply Review Meetings
- Other duties as assigned
- B.A./ B.S. degree Operations/ Supply Chain Management or related business field
- 3+ years of clinical supply chain experience in biotech industry required
- Working knowledge of current GMP/ GCP regulations required
- Prior Clinical Research training is a plus
- Experience managing multiple projects and timelines
- Excellent written and interpersonal communication skills
- Great negotiation and influence skills
- Critical thinker, ability to deal with ambiguity and problem solve independently
- Vendor management experience is a must
- Experience with ERP systems is a plus
- Experience with CMC is a plus
- Advanced MS Excel proficiency is a plus
All your information will be kept confidential according to EEO guidelines.